Prescription medicine
Heparin and taurolidine Brand names: Defencath
Heparin and taurolidine (Defencath) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the heparin and taurolidine FDA label on DailyMed (effective September 4, 2026, CorMedix Inc.); the NDA 214520 record on Drugs@FDA; every heparin and taurolidine label on DailyMed.
Highlights of the record
FDA label of September 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC).
Forms and strengths
- 40.5 mg/3ml / 3ml
Solution.
On the market
- Earliest approval on file
- November 15, 2023 Defencath, Cormedix; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 15, 2042 Defencath solution; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 9 through July 30, 2026
What is heparin and taurolidine used for?
From the label: indications and usageLIMITED POPULATION: DEFENCATH ® is indicated to reduce the incidence of catheter-related bloodstream infections (CRBSI) in adult patients with kidney failure receiving chronic hemodialysis (HD) through a central venous catheter (CVC). This drug is indicated for use in a limited and specific population of patients [see Clinical Studies (14) ]. Limitations of Use The safety and effectiveness of DEFENCATH have not been established for use in populations other than adult patients with kidney failure receiving chronic HD through a CVC. […]
FDA pharmacologic class: Anti-coagulant and Unfractionated Heparin.
Source: FDA drug label (DEFENCATH), CorMedix Inc., effective September 4, 2026 (SPL set 13b3a61e-5a4b-4afb-8fa1-d76ebdb344d6), via openFDA; the full label on DailyMed
Is there a generic for heparin and taurolidine (Defencath)?
No generic heparin and taurolidine is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Defencath solution: the compound patent runs to April 15, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for heparin and taurolidine?
The FDA Adverse Event Reporting System holds 9 reports that list heparin and taurolidine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 3 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anti-coagulants
- the pharmacologic class, with prices and generics
- Heparin and taurolidine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other